Fortress Biotech Inc Stock Price, News & Analysis

Fortress Biotech (Nasdaq: FBIO) reported Q2 2024 financial results and corporate highlights. Key points include:

1. FDA acceptance of NDA for DFD-29 (rosacea treatment) with PDUFA date of November 4, 2024.

2. FDA acceptance of BLA resubmission for cosibelimab (cSCC treatment) with PDUFA date of December 28, 2024.

3. Q2 2024 product revenue of $14.9 million, up 15% from Q1 2024.

4. Cash position of $76.2 million as of June 30, 2024.

5. Net loss of $(13.3) million, or $(0.73) per share for Q2 2024.

6. R&D expenses decreased to $12.7 million in Q2 2024 from $32.1 million in Q2 2023.

7. New loan agreement with Oaktree Capital Management, resulting in a net $15 million debt reduction.

Journey Medical (Nasdaq: DERM) reported financial results for Q2 2024. Key highlights include:

- Total revenues of $14.9 million, a 14% increase from Q1 2024
- Net loss reduced by $5.0 million to $3.4 million or $(0.17) per share
- Positive Adjusted EBITDA of $0.3 million
- Cash and cash equivalents of $23.9 million as of June 30, 2024

The company's New Drug Application for DFD-29 to treat rosacea is under FDA review with a PDUFA goal date of November 4, 2024. Journey Medical appointed Joseph M. Benesch as CFO and Michael C. Pearce to its Board of Directors. The company remains on track to deliver its 2024 financial guidance.

Checkpoint Therapeutics (Nasdaq: CKPT) reported Q2 2024 financial results and corporate updates. Key highlights include:

1. FDA accepted resubmission of BLA for cosibelimab in cSCC with PDUFA date of December 28, 2024.
2. Collaboration announced to explore cosibelimab with GC Cell's Immuncell-LC.
3. Completed registered direct offering for $12.0 million in gross proceeds.

Financial results:
- Cash position: $5.0 million as of June 30, 2024
- R&D expenses: $4.5 million, down from $13.9 million in Q2 2023
- G&A expenses: $2.2 million, slightly down from $2.3 million in Q2 2023
- Net loss: $6.7 million ($0.18 per share), improved from $16.5 million ($1.05 per share) in Q2 2023

Journey Medical (Nasdaq: DERM), a commercial-stage pharmaceutical company focusing on FDA-approved dermatological treatments, has announced it will release its second quarter 2024 financial results on August 12, 2024, after U.S. market close. The company will host a conference call and audio webcast at 4:30 p.m. ET on the same day to discuss the results and provide a corporate update.

Interested parties can join the call by dialing 1-866-777-2509 (domestic) or 1-412-317-5413 (international). Participants can also register online to receive a dial-in number. A live audio webcast will be available on the company's website and will remain accessible for approximately 30 days after the call.

Fortress Biotech (Nasdaq: FBIO) has entered into a new loan agreement with Oaktree Capital Management for up to $50 million, receiving an initial $35 million tranche. This arrangement allows Fortress to repay its prior $50 million loan due in August 2025 and extends the maturity to July 2027. The new loan has a 30-month interest-only period with an interest rate of 3-month SOFR plus 7.625%.

The company expects this agreement to provide financial flexibility for long-term expansion, asset acquisition, and execution of its commercial business and late-stage pipeline. Fortress anticipates up to three regulatory approvals on NDAs and BLAs in the next 12 months and potentially a fourth BLA filing by 2025. This strategic partnership with Oaktree supports Fortress' ability to develop innovative assets addressing areas of high unmet medical need.

Checkpoint Therapeutics (Nasdaq: CKPT) announced that the FDA has accepted its resubmitted Biologics License Application (BLA) for cosibelimab, an anti-PD-L1 antibody, for treating advanced cutaneous squamous cell carcinoma (cSCC). The FDA set a PDUFA goal date of December 28, 2024. This resubmission addresses the complete response letter (CRL) issued in December 2023, which only cited issues with the third-party contract manufacturing organization. Notably, the CRL did not raise concerns about the clinical data package, safety, or labeling for cosibelimab's approvability. Checkpoint's CEO expressed satisfaction with the FDA's acceptance and looks forward to potentially delivering cosibelimab's unique dual mechanism of action to cSCC patients.

GC Cell (KRX: 144510.KS) and Checkpoint Therapeutics (Nasdaq: CKPT) have announced a collaboration to explore the combined therapeutic potential of cosibelimab, Checkpoint's anti-PD-L1 antibody, with GC Cell's Immuncell-LC, an autologous Cytokine Induced Killer (CIK) T cell therapy. The partnership will initially focus on in vitro combination studies to evaluate synergistic effects on cancer cell destruction.

The anticipated synergy leverages cosibelimab's antibody-dependent cellular cytotoxicity (ADCC) mechanism and Immuncell-LC's CIK T cell response. Positive preliminary data could lead to future in vivo research and clinical studies. Both companies' CEOs expressed optimism about the collaboration's potential to set new standards in immuno-oncology and possibly result in commercial licensing or joint development opportunities.

Journey Medical (Nasdaq: DERM) has appointed Michael C. Pearce to its Board of Directors, effective July 9, 2024. Pearce, an experienced principal investor and advisor in the healthcare sector, has an extensive background, including roles at EP Group, Evening Post Industries (EPI), and as Chairman of Range Therapeutics. His appointment comes as Journey Medical approaches the potential FDA approval of DFD-29, a promising treatment for rosacea, in November 2024. Pearce's strategic, business, and financial expertise is expected to bring significant value to Journey Medical's leadership as it continues to pursue its corporate goals.

Fortress Biotech (Nasdaq: FBIO; FBIOP) announced a pause in dividend payments on its 9.375% Series A Cumulative Redeemable Perpetual Preferred Stock, effective July 1, 2024. This decision affects the dividend payment scheduled for July 31, 2024, and will defer around $0.7 million in monthly cash payments. The dividends will continue to accrue until further notice. The Board will regularly review this decision, considering the company’s profitability and cash flow. This move aims to maintain financial flexibility ahead of significant regulatory milestones, including potential approvals for DFD-29, cosibelimab, and CUTX-101 within the next 12 months.